High-Dose Flu Vaccine Confers Greater Protection for Elders

High-dose influenza vaccine protects elders better than a standard-dose formulation, according to a manufacturer-conducted trial in the New England Journal of Medicine.

During the 2011-2012 and 2012-2013 flu seasons, some 32,000 people aged 65 or older in the U.S. and Canada were randomized either to a high-dose trivalent formulation containing 60 µg of hemagglutinin per strain or to standard trivalent vaccine (15 µg per strain).

The study's primary endpoint, lab-confirmed influenza caused by any viral type at least 14 days after vaccination, occurred in 1.4% of the high-dose group and 1.9% of the standard-dose group. That translates to a relative efficacy for the high-dose formulation of almost 25% over the standard dose.

Yet again we are seeing the use of the highly misleading relative risk ratio to hype the efficacy of the new formulation (look! a 25% reduction!). Fortunately the actual numbers are present in this report and show the real magnitude of the effect. The normal vaccine seems to offer a 98.1% chance that a recipient will not get flu. The high dose vaccine provides a mere half of a percent more protection: 1.4% got flu as compared to 1.9% with standard vaccine. While it is true that these small percentages translate to large numbers of patients on a population basis, how do we help the individual patient weigh this very small benefit against the possible increased side effects and likely increased cost associated with the higher dose? More data is clearly needed, along with a higher commitment to statistical honesty on the part of those who report on the findings.

I have taken yearly flu vaccine for decades and have never had any serious side effects. On Dec. 12, 2013, I took the Fluzone High Dose vaccine, unaware that "high" meant 4 times the ordinary dose. Within a few days I was incapacitated by severe muscle spasms and generalized weakness. Spasms were worst in the neck, shoulders, and arms. I also experienced tinnitus for the first time in my life. Symptoms did not become tolerable until Jan. 21, 2014. Both my internist and cardiologist have recommended that I skip any future vaccines with the same antigens. I wonder why a 4x dose was recommended for the elderly. Why not 2x or 3x?

This study would have more validity if it wasn't financed by the company that makes the vaccine, and has a vested interest in selling more of its products. To often research conducted by the companies that make a product have been found to have either flawed or missing data. Research needs to be conducted by a 3rd party who has no interest except good science. Also missing the control group!

Dr. Saeks,
The control group wasn't missing, it was the standard dose flu vaccine. If you meant a placebo-control, that clinical trial wouldn't have been ethical because the flu vaccine is known to be effective and is the standard of care.
Also, while industry-sponsored studies do raise the possibility of conflicts of interest, the results aren't automatically less valid. Validity is better determined by Looking into their methodologic details, including recruitment, blinding, etc. It's difficult for many studies to be funded by a third-party, because the companies that stand to gain from a treatment, are the companies that are willing to pay to study it. Just like studies about chiropractic are likely to be funded by chiropractic colleges or organizations.

I received the high dose,was ill for 2-3 months after , Night sweats High Sed rate 130, fever over 101,weakness, doctors very concerned,warned their patients not to get the high dose, and myself not to get any flushots at all.

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